Abbreviations: MAP, mean arterial pressure; RAAS, renin-angiotensin-aldosterone system.
aTarget MAP defined as ≥75 mmHg or an increase from baseline of ≥10 mmHg without an increase in baseline vasopressor therapy.
bGIAPREZA and placebo were studied in conjunction with norepinephrine, epinephrine, dopamine, phenylephrine, and vasopressin.
cResults from the ATHOS-3 trial.
dResponse was defined as achievement of target MAP ≥75 mmHg or increase of ≥10 mmHg from baseline without an increase in baseline vasopressor therapy.
Important Safety Information
GIAPREZA™ (angiotensin II) increases blood pressure in adults with septic or other distributive shock.
Warnings and Precautions The safety of GIAPREZA was evaluated in 321 adults with septic or other distributive shock in the randomized, double-blind, placebo-controlled ATHOS-3 study. There was a higher incidence of arterial and venous thrombotic and thromboembolic events in patients who received GIAPREZA compared to placebo treated patients in the ATHOS-3 study [13% (21/163 patients) vs. 5% (8/158 patients)]. The major imbalance was in deep venous thromboses. Use concurrent venous thromboembolism prophylaxis.
Adverse Reactions The most common adverse reactions reported in greater than 10% in GIAPREZA-treated patients were thromboembolic events. Adverse reactions occurring in ≥4% of patients treated with GIAPREZA and ≥1.5% more often than placebo-treated patients in the ATHOS-3 study were thromboembolic events (including deep vein thrombosis), thrombocytopenia, tachycardia, fungal infection, delirium, acidosis, hyperglycemia, and peripheral ischemia.
Drug Interactions Angiotensin converting enzyme inhibitors may increase response to GIAPREZA.
Angiotensin II receptor blockers may reduce response to GIAPREZA.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.